A phase I open-label study with a single arm evaluating the safety, tolerability, and efficacy of MVX-ONCO-2 in patients with an advanced solid tumor.

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT05071846 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
non disponible

Titre académique
An Open Label, Single Arm, Phase I Clinical Study Assessing Safety, Tolerability, and Efficacy of MVX-ONCO-2 in Patients With Advanced Solid Tumors (ICTRP)

Titre public
MVX-ONCO-2 in Advanced Solid Tumors (ICTRP)

Maladie en cours d'investigation
Solid Tumor, Adult (ICTRP)

Intervention étudiée
Biological: MVX-ONCO-2 (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
Inclusion Criteria:

- Patient with advanced metastatic solid tumors with documented tumor progression
after at least one line of systemic therapy and for which no further standard
therapies are available, feasible or accepted by the patient. Prior exposure to an
immune checkpoint inhibitor (ICPI) is allowed. Patient with a localized disease for
which no curative therapy is available and a measurable lesion is still amenable for
RECIST assessment after biopsy (to manufacture the vaccine) are allowed (example:
GBM or sarcoma with local relapse after surgery, chemo-radiation)

- Must be 18 years of age or older at the time of signing the informed consent.

- Must have a primary tumor and/or metastasis amenable for surgery (or tap as
indicated).

- Must be willing to undergo a surgical tumor biopsy (or tap as indicated) prior to
registration.

- Must have at least 1 additional radiologically measurable lesion of the primary
cancer type, evaluable per RECIST 1.1, that will remain untouched by surgical
harvest procedure for the assessment of tumor size throughout the study.

- Must have a life expectancy estimate of at least 4 months.

- Must have Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to
1.

- Must have no major impairment of liver function: Alanine aminotransferase (ALT) =
2.5 the upper limit of the normal range (ULN) bilirubin = 1.5 ULN. Exceptions:

- Liver metastases: ALT = 5 ULN bilirubin = 3 ULN

- Documented diagnosis of Gilbert syndrome: total bilirubin = 3 ULN.

- Must have no major impairment of renal function: Estimated glomerular filtration
rate (eGFR) > 30 mL/min as calculated using the Chronic Kidney Disease-Epidemiology
Collaboration (CKD-EPI).

- Must have no major impairment of bone marrow function (without hematological support
within 7 days prior to assessment): Hemoglobin = 9.0 g/dL complete blood count
(CBC) = 2.5 109/L neutrophils = 1.5 109/L platelets = 75 109/L.

- Must have no major impairment of coagulation status: International normalized ratio
(INR) = 1.5 ULN (without anticoagulation therapy), prothrombin time (PT) or
activated partial thromboplastin time (aPTT) = ULN.

- May be male or female.

1. A male participant with a female partner of childbearing potential must agree
to remain sexually abstinent or use condoms during the treatment period with
MVX-ONCO-2 and for 60 days after the last treatment and the patient must also
refrain from donating sperm during this period.

2. A female patient is eligible to participate if she is not pregnant, not
breastfeeding, and at least one of the following conditions applies:

i. Not a woman of childbearing potential (WOCBP). OR ii. A WOCBP who has had a
negative pregnancy test within 7 days before the first study treatment and agrees to
follow contraceptive guidance during the treatment period and for at least 60 days
after the last dose of study treatment.

- Has the ability to understand the concept of a clinical study and be willing and
have the ability to comply with scheduled visits (including geographical proximity),
treatment plans, laboratory tests, and other study procedures.

- Is capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the Informed Consent Form (ICF) and in this
Protocol.

- Patient or legal representative has signed an ICF prior to any study-specific
procedures or treatment.

Exclusion Criteria:

- Has participated in any other investigational study or received an experimental
therapeutic procedure considered to interfere with the study in the 4 weeks before
Screening.

- Has received any prior cytotoxic biologic or any investigational agent treatment in
the 4 weeks (or 5 half-lives, whichever is shorter) before Screening. Chronic
treatment with non investigational gonadotropin-releasing hormone analogues or other
hormonal or supportive care is permitted.

- Has received prior radiotherapy within 2 weeks of the start of study treatment.
Prior irradiation of RECIST 1.1 target lesions is not allowed.

Note: radiotherapy of bone metastases to control pain is allowed.

- Has history of another malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.

Note: The time requirement does not apply to patients who underwent successful definitive
resection of basal cell carcinoma of the skin, superficial bladder cancer, in situ
cervical cancer, or other in situ cancers.

- Has known active central nervous system metastases and/or carcinomatous meningitis.
Patients with previously treated brain metastases may participate provided they are
stable (without evidence of progression by imaging for at least 4 weeks prior to the
first dose of study treatment and any neurologic symptoms have returned to
baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to study treatment. This exception does not
include carcinomatous meningitis, which is excluded regardless of clinical
stability.

- Has known history of positive test for HIV-1 or HIV-2 unless on established
anti-retroviral therapy (ART) for at least 4 weeks prior to treatment administration
and whose viral load is = 400 copies/mL prior to enrollment.

- Has known history of hepatitis B virus (HBV). Patients who are hepatitis B surface
antigen negative and HBV viral deoxyribonucleic acid (DNA) negative may be included
in the study. Patients who had HBV but who received an antiviral treatment and show
non-detectable viral DNA for 6 months or patients who are seropositive because of
HBV vaccine may also be included in the study.

- Has known history of hepatitis C virus (HCV). Patients who had HCV but who received
an antiviral treatment and show no detectable HCV viral deoxyribonucleic acid (DNA)
for 6 months may be included in the study.

- Has known active or recent cytomegalovirus (CMV) infection.

- Has received vaccine containing live virus within 4 weeks prior to the first dose of
study treatment. Inactivated seasonal influenza vaccines are permitted on study
without restriction.

- Has a clinically severe auto-immune condition requiring immunosuppressive
medication.

- Has a history of transplants.

- Has conditions requiring concurrent use of systemic immunosuppressants or
corticosteroids > 30 mg daily of cortisone or equivalents. Topical steroids at or
near the injection site should not be allowed.

- Use of other immunosuppressive medications within 14 days of study treatment.

- Has evidence of chronic or concurrent active infection or medical condition that
requires intravenous antibacterial, antiviral, or antifungal therapy within 14 days
of the first study treatment administration.

- Has other unresolved toxicities related to prior anticancer therapy and/or surgery.

Note: Patient must have stabilized or recovered (Grade 1 or baseline) from all prior
therapy related toxic effects of (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Number of adverse events and/or serious adverse events (ICTRP)

Tumor response;Duration of response;Progression-free survival;Overall survival (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
CATO-SMS
(ICTRP)

Contacts supplémentaires
Eugenio Fernandez;Laura Le Bouil;Eugenio Fernandez, laura.lebouil@hcuge.ch; eugenio.fernandez@hcuge.ch, +41 22 37 22 908;+41 79 55 32 431, University Hospital, Geneva, (ICTRP)

ID secondaires
MVX-2021-01 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05071846 (ICTRP)